The Swissmedic Agency Council has appointed new members to the independent expert committees (Swissmedic Medicines Expert Committees) for the 2025-2028 term of office as part of the regular overall renewal. These Committees assist Swissmedic with the scientific evaluation of authorisation applications, market surveillance and the granting of authorisations. Renowned experts from a number of medical and scientific disciplines participate in the Human Medicines Expert Committee (HMEC) for human medicinal products and in the Veterinary Medicines Expert Committee (VMEC) for veterinary medicinal products. They provide Swissmedic with additional expertise, and their additional clinical opinions make a valuable contribution to ensuring that patients in Switzerland have access to safe, effective and high-quality medicinal products.
The Swissmedic Medicines Expert Committees (SMEC) have begun the 2025–2028 period of office with a new line-up
17.03.2025
Swissmedic handles authorisations and market surveillance of human and veterinary medicinal products in conjunction with independent scientific advisory committees whose members are selected by the Swissmedic Agency Council for a four-year period of office. The experts in medicine, pharmaceutics, science and other specialised fields contribute their comprehensive knowledge and experience gained from clinical practice. They disclose any conflicts of interest on an annual basis so that these can be identified and taken into account at an early stage. Swissmedic publishes the principles for provision of independent advice, the conflicts of interest, and the dates of the ordinary meetings on its website.
The ordinary HMEC Committee usually meets once a month, and the VMEC about six times per year. Swissmedic can additionally draw on specific members to provide partial reviews or individual expert reports as needed. In this context they answer specialist questions arising in connection with or independently of pending applications. The experts review the data submitted by companies and provide an expert assessment. These recommendations, which are not binding on Swissmedic, supplement the assessments made by Swissmedic experts and enable research and clinical practice to be considered when evaluating the benefit-risk profile of medicinal products. The final decision on applications is always taken by Swissmedic.
Human Medicines Expert Committee (HMEC)
The Human Medicines Expert Committee (HMEC) chaired by Prof. Andreas Wicki generally meets once a month, primarily to discuss new authorisations or additional indications for human medicinal products.
The HMEC currently comprises seven ordinary members with extensive experience and expertise in oncology, internal medicine, infectious diseases, cardiology and toxicology. There are also 49 extraordinary members who are consulted on specific questions and five advisory members who assist Swissmedic with their specialised knowledge. 18 of the 61 members (29.5%) are women, including two experts in gender medicine.
HMEC President Andreas Wicki, who is Deputy Director of the Department of Medical Oncology and Haematology at Zurich University Hospital, has a positive impression of the ordinary HMEC Committee after its first three meetings:
«It didn’t take us long to find common ground. Our interaction is productive, the discussions are active and professional. Together with the constructive collaboration with Swissmedic, this will create a strong basis for our ongoing tasks in the new period of office. In the coming years we will be aiming to focus particularly on how best to recommend authorisations for rare diseases, especially in cases in which there are too few patients for a randomised controlled trial.»
The work of the HMEC: «The Expert Committee»
Swissmedic «Visible» 2/2020
The article explains the role, composition and work of the HMEC in performing scientific assessments of medicinal products.
Veterinary Medicines Expert Committee (VMEC)
The Veterinary Medicines Expert Committee (VMEC), chaired by Dr Barbara Knutti, meets about six times per year to discuss veterinary medicinal products. The VMEC comprises eight ordinary and nine extraordinary members. Women account for 47% of the VMEC (8 of 17 members). Following the revision of the SMEC Regulation, which came into force on 1 January 2025, the maximum number of ordinary VMEC members was increased from seven to nine to enable the Committee to be enlarged if needed.
VMEC President Barbara Knutti, who is a self-employed veterinarian and heads a specialised centre for equine reproduction, is also satisfied after the first meeting:
«The VMEC’s new period of office got off to a good start. With our interdisciplinary expertise and experience with different target species we can continue to make a contribution to scientifically grounded assessment of veterinary medicinal products – for the benefit of animals, their owners and consumers.»
The work of the VMEC: «Animals and humans in the spotlight»
Swissmedic «Visible» 3/2021
An interview with VMEC President Barbara Knutti.
Contact
Swissmedic Medicines Expert Committees
Division Regulatory Operations & Development
Hallerstrasse 7
3012 Bern